Newsletter | November 16, 2023

11.16.23 -- Deciphering New U.S. Laws Around Predetermined Change Control Plans

FEATURED EDITORIAL

Deciphering New U.S. Laws Around Predetermined Change Control Plans

As is typical with legislative language, the language used in Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) can be difficult to understand, with multiple cross-references to existing laws and use of legal terminology that can be cryptic. Here's our interpretation of key passages relevant to post market change controls and implementing a predetermined change control plan (PCCP) for Class II software as a medical device (SaMD) products.

INDUSTRY INSIGHTS

A New Mindset For Combination Product Development

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

Considerations When Choosing A Biomaterial For Your Orthopedic Device

In the second part of this series, we focus on Biomerix Thermoset Polyurethane and the properties that make it ideal for use in rotator cuff repair devices.

Annex 1 Compliance Guidelines For Biological Indicator Users

Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance, whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.

Conquering The Big And Small Challenges Of Micromanufacturing

Meeting the tight tolerances of micro-sized medical components requires absolute precision, experience, and innovative approaches to overcome challenges in advanced micromanufacturing technology.

Broadening User Requirements When Selecting Valves For Medical Devices

Choosing the right valves for specific medical device applications can be as frustrating as the process of buying a new car.

Tech Talk: Xover Valve Flow Cytometry

The Lee Company's Xover Valve excels wherever low crossover, low shear, and low internal volume switching is required. The valves are often used to supply sheath fluid, control samples upstream of the flow cell, or introduce cleaners or reagents to the flow stream.

Benefits Of RFID For Medical Device OEMs

Examine why OEMs are increasingly turning to integrated RFID to add value to their products in an increasingly crowded marketplace and discover key applications for RFID in the medical device field.

ARTICLES YOU MAY HAVE MISSED

FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products

Emerging Trends In Microneedle Drug Delivery Systems

Medical Device Post-Market Change Controls And FDA 510(k) Software Modification Guidance

India Aims To Boost Medical Device Industry With New Initiative

EU Medtech Labeling Compliance And The Competitive Advantage Of A Digitalized Process

RESOURCES

Heat Shrink Tubing Components

Fully Automated Pouch Seal Inspection Solution

Prototype Plus: Design To Production, Simplified

Valves

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